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Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients

This study has been terminated.
(Surgeons change in preference for perioperative warming.)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01626690
First received: June 12, 2012
Last updated: July 20, 2016
Last verified: July 2016
Results First Received: January 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Perioperative Hypothermia
Interventions: Device: Bair-Paws Warming Device
Device: Bair-Hugger Warming Device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pre-Warming Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
Control Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).

Participant Flow:   Overall Study
    Pre-Warming     Control  
STARTED     49     51  
COMPLETED     47     51  
NOT COMPLETED     2     0  
Protocol Violation                 1                 0  
Adverse Event                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Pre-Warming Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
Control Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
Total Total of all reporting groups

Baseline Measures
    Pre-Warming     Control     Total  
Number of Participants  
[units: participants]
  47     51     98  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     23     44  
>=65 years     26     28     54  
Age  
[units: years]
Mean (Standard Deviation)
  66.1  (6.37)     66.5  (7.41)     66.3  (6.9)  
Gender  
[units: participants]
     
Female     27     24     51  
Male     20     27     47  
Region of Enrollment  
[units: participants]
     
United States     47     51     98  
Baseline Temperature  
[units: Degrees Celisius]
Mean (Standard Deviation)
  36.6  (0.4)     36.7  (0.37)     36.6  (0.39)  



  Outcome Measures
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1.  Primary:   Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..   [ Time Frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). ]

2.  Secondary:   Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.   [ Time Frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). ]

3.  Secondary:   Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.   [ Time Frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). ]

4.  Secondary:   Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.   [ Time Frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). ]

5.  Secondary:   Incidence of Postoperative Shivering in Recovery Room.   [ Time Frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). ]

6.  Secondary:   Intraoperative Blood Loss.   [ Time Frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). ]

7.  Secondary:   Incidence of Perioperative Cardiac Events.   [ Time Frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). ]

8.  Secondary:   Temporal Artery Verus SpotOn (3M) Temperature Readings.   [ Time Frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kristopher Schroeder, MD
Organization: University of Wisconsin School of Medicine and Public Health
phone: 608-263-8100
e-mail: kmschro1@wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01626690     History of Changes
Other Study ID Numbers: 2011-0823
Study First Received: June 12, 2012
Results First Received: January 21, 2016
Last Updated: July 20, 2016
Health Authority: United States: Institutional Review Board